Job Location: Texas
The Clinical Research Associate (CRA) monitors activities at clinical trials sites to assure adherence to Good Clinical Practices (GCP), standard operating procedures, and study protocols. The CRA reviews regulatory documents as necessary, and prepares site visit reports. The person in this position is involved in the selection of potential clinical investigators and determines if facilities are adequate based on protocol requirements.
REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES
· The position requires a Bachelor’s degree in life sciences, nursing degree, or equivalent, plus a minimum of one year experience as a clinical monitor.
· Demonstrated knowledge and a clear understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, drug safety and regulatory issues, and report generation.
· Must have proficiency with ICH/GCP guidelines.
· Excellent verbal and written communication skills, organizational skills, time-management, customer service, and interpersonal skills are required.
· Must be able to work independently.
· Certified Clinical Research Associate (CCRA) desired, but not required.